Parents Urged to Stop Using Infant Sleep Positioners Following Fatalities

By Jeff Plungis -
Sep 29, 2010

Parents should immediately stop
using products that help keep infants in place while sleeping,
the U.S. Consumer Product Safety Commission and the Food and
Drug Administration said.

The two agencies received 12 reports of babies who died
when they suffocated after the devices were placed in cribs or
bassinets, according to a statement today. The CPSC also
received dozens of reports of infants rolling off their backs
into potentially hazardous positions, it said.

“The deaths and dangerous situations resulting from the
use of infant sleep positioners are a serious concern,” CPSC
Chairman Inez Tenenbaum said in the statement. “We urge parents
and caregivers to take our warning seriously.”

Most sleep positioners are flat mats with side bolsters or
a wedge-shaped mat with bolsters, the agencies said. Both types
are marketed to help keep infants on their backs while sleeping
to reduce the risk of Sudden Infant Death Syndrome.

The fatalities were reported for babies from 1 to 5 months
old who either suffocated in the position or died after becoming
trapped between the device and the side of their crib or
bassinet, the agencies said.

The FDA has approved 18 sleep-positioning devices for use
in reducing risks from reflux or flat-head syndrome, said Joshua Sharfstein, the FDA’s principal deputy commissioner, a
pediatrician. The regulator hasn’t cleared any device for
preventing or reducing the risk of sudden death. Both agencies
said they’re not aware of any scientific studies that
demonstrate sleep positioners prevent SIDS or suffocation.

Sleep Positioner Retailers

Among the companies making sleep positioners are Life
Innovations LLC, Kamber Corp., the Ludlow Company LP, Pedicraft
Inc. and Olympic Medical Corp., according to the FDA. The
products are sold by retailers led by Wal-Mart Stores Inc. and
Target Corp.

Both agencies are working to remove products from stores,
Sharfstein said. In the past month, the FDA asked all companies
making the sleep positioners to pull their products, he said.
Five companies have agreed, he said.

The agencies aren’t issuing a recall and consumers won’t
receive a refund or a repaired product, Tenenbaum said. Recalls
have to be negotiated with a company after a defect is found,
she said. Recalls may still occur, Sharfstein said.

“We will use all of our authority to protect children,”
Sharfstein said. “We do not want these types of sleep
positioners used. We have asked the companies to stop selling
them.”

Sufficient evidence shows a potential risk from using
positioners, said Rachel Moon, a doctor and chairman of the SIDS
Task Force at the American Academy of Pediatrics. Instructions
for positioners usually tell parents to stop using the product
when babies start to move, she said.

“You cannot predict when a child will begin to do
something,” Moon said. “You have to assume your baby will move
at any time.”